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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT03652493
Other study ID # 2017-004764-35
Secondary ID
Status Terminated
Phase Phase 2
First received
Last updated
Start date September 10, 2018
Est. completion date April 27, 2021

Study information

Verified date April 2021
Source Centre Francois Baclesse
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The investigators propose a phase II study to evaluate the efficacy of carboplatin monotherapy in the tumor subgroup of metastatic castration-resistant prostatic carcinomas with somatic abnormality in the Homologous Recombination (HR) pathway. This study may also better characterize the molecular abnormalities of tumors required for the carboplatin response


Recruitment information / eligibility

Status Terminated
Enrollment 16
Est. completion date April 27, 2021
Est. primary completion date April 27, 2021
Accepts healthy volunteers No
Gender Male
Age group 18 Years and older
Eligibility Inclusion Criteria: - Patients > 18 years old - Patients with adenocarcinoma or poorly differentiated prostate carcinoma, histologically confirmed (small-cell histology or high-grade neuroendocrine histology excluded) - Tumor presenting a somatic pathogenic variant likely to alter the homologous recombination pathway previously detected on a tumor biopsy or on circulating tumor DNA, or germinal mutation among the list of genes defined in the study - Castration-resistant tumor defined by progression despite well-conducted androgen deprivation treatment: testosterone =50ng /dL agonist / antagonist of luteinizing hormone-releasing hormone (LHRH) or surgical castration. The patient must agree to continue concomitant LHRH-mediated (agonist or antagonist) therapy throughout the duration of the study regimen for patients with no history of surgical castration. - Patients must have performed at least one line of chemotherapy by taxane in case of castration resistance: - Patients who have received docetaxel treatment in a hormone-sensitive situation must have received at least treatment with cabazitaxel in case of castration resistance - Patients who have not received chemotherapy in a hormone-sensitive situation must have received docetaxel AND cabazitaxel or have a contraindication to discontinue treatment. - Patients must have been treated with at least 2nd generation hormone therapy (eg, abiraterone acetate or enzalutamide) - Patients may have been treated with a poly (ADP-ribose) polymerase inhibitor (PARP) - Performance Status <2 - Metastatic disease progressive Exclusion Criteria: - Absence of previous treatment with taxane in situation of sensitivity or resistance to castration. - Absence of previous treatment with cabazitaxel in case of resistance to castration (except contraindication explaining the non-administration of treatment) - No treatment with 2nd generation hormone therapy (eg abiraterone acetate or enzalutamide) unless contraindicated to explain non-administration of treatment - Previous treatment with platinum - Symptomatic and untreated central nervous system (CNS) metastases. Patients with asymptomatic and pre-treated CNS metastases are included if they are clinically stable (not requiring corticosteroid therapy for 28 days) and must have a brain MRI evaluation at screening and during follow-up.

Study Design


Intervention

Drug:
Carboplatin
Tumoral evaluation every 3 cycles

Locations

Country Name City State
France Centre François Baclesse Caen
France Centre Oscar Lambret Lille
France Chu Rouen Rouen
France Institut Gustave ROUSSy IGR Villejuif

Sponsors (3)

Lead Sponsor Collaborator
Centre Francois Baclesse GIRCI (French Interregional Group of Clinical Research and Innovation), Ligue Contre le Cancer (French association Against Cancer)

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary Efficacy of carboplatin on metastatic prostatic carcinoma resistant to castration Efficacy of carboplatin: The best radiological tumoral response rate Tumoral response rate (TR) defined according to the recommendations of the PCWG3 criteria : Objective radiological response Up to 27 weeks (9 cycles)
Primary Efficacy of carboplatin: biological response rate defined by value of PSA Biological response rate (TR) defined according to the recommendations of the PCWG3 criteria : Decrease of PSA = 50%, Up to 27 weeks (9 cycles)
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